Lupin’s generic version of ProAir HFA approved by the FDA

The FDA has approved Lupin’s generic version of Teva’s ProAir HFA albuterol MDI for the treatment of asthma, the company said. Lupin said that it will manufacture the inhaler at its facility in Indore, India.

Lupin CEO Vinita Gupta commented, “Approval of our generic albuterol MDI is a significant milestone in our complex generics evolution and a validation of our Inhalation team’s development capabilities, backed by our global manufacturing strength in handling multiple dosage forms. The approval is timely as albuterol MDI is a key rescue inhalation product for asthma patients who are at an increased risk of COVID-related complications.  We look forward to launching the product this quarter and expect a steady ramp-up through the fiscal year.”

In April 2020, the FDA tentatively approved Lupin’s generic version of Sunovion’s Brovana arformoterol inhalation solution.

Read the Lupin press release.

Share

published on

December 9-December 11: DDL 2026, Edinburgh, Scotland

April 27-30: RDD Europe 2027, Antibes, France

June 30: RespireX 2027, Boston, MA, USA